Project Overview +

The goal of this project is to standardize the informed consent process across biobank initiatives. This project includes the development of an ethically and socially responsible consent form for the MICHR biobank.

Aims +

Aim 1. Develop a simplified and electronically compatible ontology for the essential elements of informed consent for biobanks.

Aim 2. Using a model biobank consent form approved by the University of Michigan IRB, develop and test a novel consent process (also IRB approved), purposefully designed to promote understanding of and trust in biobanks.

Participants +

Eligible participants in the MICHR recruitment database

Intervention +

This project is based on a research plan that incorporates 4 separate tasks:

Task 1: Develop a model biobank consent form based on major common elements from other IRB-approved consent forms, and get IRB approval for the new model consent form.

Task 2: Develop a simplified and electronically adaptable ontology for the essential elements of informed consent for biobanks (related to Specific Aim #1).

Task 3: Develop and test a novel consent process, purposefully designed to promote understanding of and trust in biobanks (related to Specific Aim #2).

Task 4: Conduct 2 in-person meetings between the UM and UT Houston biobanks to plan reports and publications.

Findings +

This project is ongoing and will form the foundation of the MICHR BioLibrary, now under development with Blake J. Roessler, M.D, Department of Internal Medicine, University of Michigan Health System. The purpose of the BioLibrary is to establish and maintain a scientifically useful and ethically responsible University of Michigan Health System based Genomic DNA Biolibrary.

BioBank Consent

09/01/2010 - 08/31/2011

Sponsor(s)

National Center for Research Resources

Principal Investigator:

Kenneth J. Pienta, MD

Co-Investigator(s):

Lawrence C. An, MD
Alla Karnovsky, PhD
Frank J. Manion, MS
Nicholas H. Steneck, PhD